Recent Developments in Quality by Design for Pharmaceutical Products
15 October 2015
ISPE Turkey Affiliates 2015 Fall Seminar around the theme of Recent Developments in Quality by Design for Pharmaceutical Products will be held on October 15, 2015 at Faculty of Pharmacy of Istanbul University.
The seminar will include presentations and case studies applying advanced science and risk based approaches in pharmaceutical development. The process to define the quality target product profile and patient centric product design will be presented by Dr. Marcel de Matas, specifications in QbD development including clinically relevant specifications will be presented by Dr. Paul Dickinson and product/process design and understanding will be presented by Dr. Buket Aksu in an interactive workshop setting.
We look forward to your presence in this important seminar which will highlight the recent developments in QbD for pharmaceutical products.
Deadline for registration: 30 September 2015
Drug Shortages Prevention Plan was developed by ISPE and its expert pharmaceutical and biopharmaceutical industry members and describes how industry can best prevent drug shortages from occurring by discovering root causes and through creating and sustaining organizational cultures supported by leadership, business processes and quality systems.
The ISPE Drug Shortages Prevention Plan is based upon ISPEs groundbreaking 2013 ISPE Drug Shortages Survey, which provided clear evidence that mitigating shortages requires a holistic approach and careful alignment of organizational aspects people as well as technical aspects of process and production.
ISPE Turkey Affiliates Seminar around the theme From Biotechnology to Social Media, Pharmacovigilance Practices on a Broad Spectrum took place on 08 June 2015 at Point Hotel Barbaros, Istanbul.
During the opening speech of Fatma Taman, Chair of ISPE Turkey Affiliate, Prof. Dr. Ahmet Araman was recognized for his valuable contributions to the Affiliate and a moment of silence was held for Zehra Gürol, departed member of the Affiliates Board.
Prof. Dr. Semra Şardaş from Toxicology Department of Marmara Universitys Faculty of Pharmacy held a speech on the history of pharmacovigilance and continued her presentation around the topic of the safety of biological products. Pharmacovigilance practices for biotechnological medicinal products and biosimilars were presented by Dr. Devrim Satık, Head of community of practice for biotechnological medicines and biosimilars at AİFD (Association of Research-Based Pharmaceutical Companies, in Turkey). Following the presentation about pharmacovigilance in practice held by Rabia Ayşe Çetin, Director for Pharmacovigilance at Delta PV, Dr. Eren Özçağlı from the Toxicology Department of Istanbul Universitys Faculty of Pharmacy elaborated on the usage of social media for pharmacovigilance. Finally Gürkan Budak, Application Manager at BTS made a demonstration about the management of pharmacovigilance requirements with electronic systems.
Motivated to enhance the activities of the Affiliate on its 10th year anniversary, the new Board has taken over by the General Assembly held after the lunch break of the Seminar.
In the QbD & PAT* Workshop which took place on 26 May 2015 at Bayer Türk, presentations about QbD Applications on Solid Dosage Forms were held by Prof. Dr. Yıldız Özsoy Erginer (Istanbul University, Faculty of Pharmacy, Pharmaceutical Technology Department), Gizem Yeğen (Pharmaceutical Engineering , Istanbul University Health Sciences Institute) and Önder Demir (Pharmaceutical Engineering , Istanbul University Health Sciences Institute). Presentations which included Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) of tablet dosage forms, Artificial Intelligence Programs and several case studies were very well received by the audience.
* QbD: Quality by Design; PAT: Process Analytical Technologies
The 2015 ISPE Europe Annual Conference was held on 4 - 7 May in Frankfurt. Presentations and discussions around the topics like political and economic situation of the pharmaceutical industry in Europe, benchmarking for implementations of Regulatory Authorities, integrated quality and production systems, facilities of the future, innovation for effective business solutions and regulatory compliance and drug shortages in Europe and beyond were very well received by the audience.
Ms. Fatma Taman, Chair of ISPE Turkey Affiliate, held a presentation about Mass Serialization and Track & Trace Applications in Turkey and elaborated on the transition process and issues to be considered during the implementation of the 2D system. On the other hand, Ms. Buket Hekiman, General Secretary of ISPE Turkey Affiliate, was the emcee for ISPEs presentation explaining membership benefits for non-member conference attendees.
ISPE Turkey Student Chapter held a Career Day Event on 2 May 2015 with the participation of 120 students from Pharmacy Faculties of Istanbul University, Marmara University, Yeni Yüzyıl University, Medipol University, Yeditepe University, Bezmialem University, Hacettepe University and Anadolu University. Following the opening speech of Prof. Dr. Ahmet Araman, Dean of Istanbul University Faculty of Pharmacy, managers from various pharmaceutical companies such as Sandoz, Santa Farma, Abbott and Abbvie elaborated on their personel experience in the industry and presented career opportunities in their respective companies to the students.
Representing the pharmaceutical industry, ISPE Turkey Affiliate has participated to the workshop organized by KIPLAS (The Chemicals, Petroleum, Rubber and Plastics Industry Employers Association of Turkey) for the review of Professional Standards on March 4-6, 2015 and assisted to the revision of the professional standard for Pharmaceutical Manufacturing Technician (Level 4) considering the difficulties previously encountered at common application. After the review of the document by a specialist at writing professional standards, a second workshop took place on March 23-25 and the document has been simplified once again to be suitable to the usage of the entire industry.
* QbD: Quality by Design; PAT: Process Analytical Technologies
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